Drug Master Files for: CHOLINE FENOFIBRATE

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CHOLINE FENOFIBRATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10598	I	II	12/2/1993	GENZYME PHARMACEUTICALS	SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC)
11247	A	IV	12/12/1994	LIPOID GMBH	LIPOID PC 14:0/14:0 (1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DMPC))
11407	I	II	3/28/1995	AVANTI POLAR LIPIDS INC	1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE
11464	A	II	4/12/1995	NOF CORP	DIMYRISTOYL PHOSPHATIDYL CHOLINE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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